Kornimate/medical-research-clean huggingface dataset:
a follow-up study for a phase iii, efficacy trial in inactivated enterovirus type 71 (ev71) vaccine

Conditions: Hand, Foot and Mouth Disease

Summary: the purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of ev71 vaccines in preventing hand, foot and mouth disease caused by ev71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

the phase iii, efficacy trial of inactivated vaccine (vero cell) against ev71 has completed on march 2013 in china. the data from the phase iii study suggested that the inactivated ev71 vaccine had protection effects on healthy chinese infants against hand, foot and mouth disease caused by ev71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence. this study is the phase iii, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.

Eligibility criteria:
inclusion criteria: * all subjects vaccinated at least one injection of ev71 vaccine or the placebo in the phase iii efficacy trial. exclusion criteria: * subjects who refuse to continue in the study.

Keywords: ev71 vaccine ev71-associated hfmd efficacy safety immune persistence
multimodal ultrasound in peripheral neuropathy

Conditions: Peripheral Neuropathy

Summary: this study will enforce the role of ultrasound in early diagnosis and screening on peripheral neuropathy in comparison with other modalities.

each case will undergo informed written consent and will be told the aim of the study including benefits, no harm from this procedure to the participants.

Eligibility criteria:
inclusion criteria: * patients with clinical symptoms of peripheral neuropathy exclusion criteria: * patients with unhealthy tissue texture to put on probe
problems with immune recovery in the gut tissue

Conditions: Human Immunodeficiency Virus

Summary: the aim of this study is to find out if the process of hiv replication in the lymph tissue and gut tissue of people taking hiv drugs causes long-term damage to the ability of the gut to protect you from other infections and health problems.


Eligibility criteria:
inclusion criteria: hiv+ individuals * seropositive for hiv * on art for at least 12 months * seropositive for herpes simplex type 2 and cytomegalovirus * age ≥ 18 years * negative pregnancy test for eligible women of childbearing potential hiv- individuals * seronegative for hiv * seropositive for herpes simplex type 2 and cytomegalovirus * age ≥ 18 years * negative pregnancy test for eligible women of childbearing potential exclusion criteria: * taking daily suppressive therapy for herpes simplex type 2 * contraindication to surgical \& endoscopic procedures (as judged by pi) * psychiatric or psychological illness that would make adherence to protocol procedures unlikely * pregnancy

Keywords: hiv 1 herpes simplex type 2 treatment experienced
study of cp-751,871 in combination with sunitinib in patients with advanced solid tumors

Conditions: Advanced Cancer; Advanced Solid Tumors

Summary: the study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of cp-751,871 and sunitinib when given in combination with advanced solid tumors.

the study was closed to enrollment on 14 jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with pfizer's business decision to stop development of the figitumumab compound. safety concerns did not contribute to the decision to terminate this clinical trial.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists. * ecog performance status of 0 or 1; * total igf-1 level ≥100 ng/ml; * ecog performance status of 0 or 1 * adequate bone marrow, renal, and hepatic function exclusion criteria: * concurrent treatment with any antitumor agents with the exception of lhrh agnosits for prostate cancer patients * treatment with any other investigational therapy within 4 weeks prior to study treatment * major surgery within 4 weeks of study treatment * prior treatment that may increase the risk of cardiac complications * ongoing cardiac dysrhythmias of nci ctcae grade 2 or greater * significant active cardiac disease, including hypertension that cannot be controlled by medications * greater than three (3) prior lines of cytotoxic therapy; * active infection * prior igf-ir targeted therapy;
pav vs assist control after failed sbt

Conditions: Weaning Mode Comparison

Summary: the primary aim of this research is to determine the feasibility of conducting a randomized controlled trial comparing two ventilation modes in patients admitted to the icu who require mechanical ventilation. the investigators plan to include patients on mechanical ventilation with low support (pao2/fio2 ratio \> 200, fio2 \< 0.5 and peep \< 8) for a period no longer than 48 hrs. there are a number of potential barriers to enroll patients in the study. importantly patients will have to be enrolled within 48 hours from the time they meet inclusion criteria. the secondary aims are to determine the impact of proportional assist-ventilation (pav) versus volume assist-control (vac) ventilation by evaluating the number of ventilation-free days, development of intensive care unit (icu) delirium, use of sedative/ analgesic medications, use of antipsychotic medications, length of stay in the intensive care unit and hospital, reintubations within 24 hours, adverse events, and mortality in the two groups of patients.

overview of design randomized controlled pilot study comparing mechanical ventilation modes and daily spontaneous trial combination, in patients requiring invasive mechanical ventilation with low ventilator support (pao2/fio2 ratio \> 200, fio2 \< 0.5 \& peep \<8) for a period not greater than 48 hrs. hypothesis the investigators hypothesize that 50 % of patients approached will agree to enrollment in this clinical trial over a period of 4 months. the investigators hypothesize 80% of the patients meeting inclusion criteria will be approached in a timely manner. the investigators also propose that pav mode ventilation will be superior to acv based on clinical outcome measurements. study subjects consecutive adult patients requiring invasive mechanical ventilation on low ventilator support (as mentioned above) for a period not greater than 48 hrs will be enrolled if they or their proxy consent for the study. the study will be performed in the intensive care units of university of louisville and jewish hospital in louisville, ky.

Eligibility criteria:
inclusion criteria: 1. age \>18 yrs old 2. patient or proxy available in the hospital to consent 3. receipt of invasive mechanical ventilation on low ventilator support (po2/fio2 ratio \>200, fio2 \<60% \& peep \<8) for a period not greater than 48 hrs exclusion criteria: 1. pregnant patients 2. terminal diseases (e.g. advanced or metastatic malignancy, liver cirrhosis with an estimated 3 month mortality \> 50%) 3. severely depressed respiratory drive 4. receipt of neuromuscular blocker 5. bronchopleural fistula 6. inability to obtain consent from patients or their proxies.
the effect of a novel blueberry supplement on dry eye disease

Conditions: Dry Eye

Summary: the objective of this study is to evaluate the efficacy of a novel oral supplement (gummy bear) with blueberry powder on reducing dry eye signs and symptoms and assess its safety.


Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: 1. is at least 18 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. is willing and anticipates to be able to comply with the daily intake of 3 gummy bears twice daily for 4 weeks; 5. as per tfos dews ii13, has dry eye symptoms as determined by an osdi score ≥ 13 or deq-5 ≥ 6, and at least one of the following: 1. tear film osmolarity ≥ 308 mosm/l or interocular difference \> 8 mosm/l 2. non-invasive tear film break-up time of \<10 seconds in at least one eye 3. more than 5 spots of corneal staining or \> 9 conjunctiva spots or lid margin staining (≥ 2mm length \& ≥ 25% width) in at least one eye. exclusion criteria: a person will be excluded from the study if he/she: 1. is participating in any concurrent clinical or research study; 2. currently wears, or has worn contact lenses in the past 3 months; 3. has symptoms/ signs of severe dry eye, defined by an osdi score ≥ 33 and at least one of the following: 1. corneal staining grade ≥ 3 (oxford scale) 2. non-invasive tear film break-up time of ≤ 3 seconds in at least one eye; 4. has any known active\* ocular disease and/or infection; 5. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 6. is using any systemic or topical medications (including topical corticosteroids/ nsaids or glaucoma medications) that in the opinion of the investigator may affect a study outcome variable; 7. is currently taking, or has taken, any supplements containing anti-oxidants in the last three months; 8. has started taking omega-3 supplements within the last 3 months or intend to start them during the study; 9. has a known sensitivity or an allergy to ingredients of the gummy bears; 10. has been diagnosed with glucose-6-phosphate dehydrogenase (g6pd) deficiency; 11. has a known sensitivity to the diagnostic pharmaceuticals to be used in the study; 12. is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report); 13. has undergone refractive error surgery or intraocular surgery; 14. is a member of core directly involved in the study; 15. has taken part in another (pharmaceutical) research study within the last 30 days. * for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
pulmonary arterial hypertension in systemic sclerosis

Conditions: Systemic Sclerosis; Pulmonary Arterial Hypertension

Summary: the purpose of this study is to evaluate the role of stress echocardiography, compared to standard echocardiography in the early identification of pulmonary arterial hypertension in systemic sclerosis. to evaluate the role of bnp in this setting.to analyze data recorded with respect to the parameters commonly used for ssc evaluation (eg thorax hrct, pulmonary function tests + dlco, nailfold capillaroscopy, etc); these parameters are available starting for 1999.


Eligibility criteria:
inclusion criteria: * patients with systemic sclerosis according to leroy criteria exclusion criteria: * pregnancy * significant valvular disease * low left ventricular function upon echocardiography (ejection fraction\<55%) * history of atrial fibrillation, myocardial infarction, pulmonary thromboembolisms, neoplasia or severe hepatic disease.
biomarkers and clinical features of metastatic breast cancer in patients treated with cdk4/6 inhibitors

Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8

Summary: this study investigates the clinical course of cdk4/6 inhibitor treated patients in the real-world setting among patients with breast cancer. cdk4/6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. studying samples of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy, from patients with breast cancer that has spread to the other places in the body (metastatic) may help doctors learn more about cancer and the development of drug resistance in patients, and predict how well patients will respond to treatment.

primary objectives: i. delineate clinical features of disease progression and responses to subsequent therapy following progression on ciclib-based therapy. ii. define pharmacogenomics relationships that could provide a more precise approach to drug dosing. iii. interrogate biomarkers related to response and acquired resistance in standard clinical practice. iv. develop patient-derived models from resistant disease to functionally assess the mechanisms occurring with resistance. v. elucidate the socio-demographic features related to the use of ciclibs clinically in the roswell park catchment area. outline: patients electronic medical records are reviewed to capture clinical information, and patients undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples for diagnosis/treatment decision, biomarker assessments, and description of mechanisms of resistance/response related to ciclib-therapy.

Eligibility criteria:
inclusion criteria: * all adult patients with er+/her2- metastatic breast cancer or hr+/her2-node positive, high risk early breast cancer who are being or have been treated with ciclib-based therapies are eligible for inclusion in this study * this includes patients receiving standard of care therapy for er+/her2- metastatic breast cancer, as well as those who would be eligible to participate in a non-interventional study while on a clinical study open at roswell park or st. vincent's hospital * screening will occur in breast oncology clinic, by review of patient medical records for the pending, ongoing, or past treatment with ciclib-based therapy * participant must understand the prospective nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form exclusion criteria: * pregnant of nursing female subjects * unwilling or unable to follow protocol requirements
boron neutron capture therapy, radiation therapy, and temozolomide in treating patients with newly diagnosed glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: boron neutron capture therapy and radiation therapy use high-energy x-rays and other types of radiation to kill tumor cells. drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving boron neutron capture therapy followed by radiation therapy and temozolomide may kill more tumor cells. purpose: this phase ii trial is studying the side effects of giving boron neutron capture therapy together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.

objectives: * evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant temozolomide. * evaluate tumor response in patients treated with this regimen. * evaluate the adverse effects of this regimen in these patients. outline: this is a multicenter study. patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and adjuvant oral temozolomide.

Eligibility criteria:
disease characteristics: * histologically confirmed glioblastoma multiforme * newly diagnosed disease * tumor located at a supratentorial hemisphere * deepest part of tumor \< 6 cm from the scalp * bottom of the tumor \> 6 cm from the scalp allowed provided air instillation into tumor-removed cavity is possible * no cerebrospinal fluid dissemination patient characteristics: * karnofsky performance status 70-100% * life expectancy \> 3 months * leukocyte count ≥ 3,000/μl * platelet count ≥ 10.0 × 10\^4/μl * hemoglobin ≥ 8.0 g/dl * serum creatinine ≤ 1.5 mg/dl * alt and ast ≤ 100 iu/l * no phenylketonuria * not pregnant or nursing * no nyha class iii-iv heart failure * no patient whose participation in the present study is considered inappropriate by a principal investigator or clinical investigator prior concurrent therapy: * no prior chemotherapy or radiotherapy

Keywords: adult giant cell glioblastoma adult glioblastoma adult gliosarcoma
brilinta clinical experience investigation

Conditions: Acute Coronary Syndrome, Old Myocardial Infarction

Summary: to confirm the following safety topics in patients to be treated with brilinta tablets 60 mg or 90 mg (hereinafter referred to as "brilinta") in clinical practice in the post-marketing phase. 1. profile and incidence of adrs the cei will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc. 2. profile and incidence of adrs not expected from "precautions for use" of the ticagrelor jpi 3. efficacy: profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke) 4. factors which may affect safety or efficacy of ticagrelor


Eligibility criteria:
inclusion criteria: * patients treated with brilinta for acs or omi, which is the indication of the drug. exclusion criteria: -
protocol for prehabilitation service implementation in catalonia

Conditions: Chronic Disease

Summary: trimodal prehabilitation consists of a short-term (\~ four to six weeks) preventive intervention to: i) enhance aerobic capacity and daily physical activity; ii) nutritional optimization; and, iii) psychological support before a major surgical procedure. the final aim of prehabilitation is to decrease surgical complications and speed-up postoperative functional recovery.

this is a preventive intervention addressed to high risk candidates for major surgical procedures carried out for a period of approximately four weeks before surgery aiming at reducing complications and enhancing post-surgical recovery. it combines: i) high-intensity endurance exercise training and promotion of daily physical activity; ii) nutritional balance; and, iii) psychological support. the intervention is currently deployed as mainstream service at hospital clinic in several types of major surgeries. during fall 2017, three multidisciplinary workshops using a design-thinking approach were carried out to refine the service workflow and to explore the potential for service scalability. the outcomes of the co-design process provided a robust background for the design of a future personalized perioperative care service at regional level covering three phases: prehabilitation, in-patient care, and, post-discharge care. the current study protocol aims to assess cost-effectiveness of prehabilitation as mainstream service in the ongoing deployment at hospital clinic, as well as to generate a roadmap for regional scalability of the service. it is planned as a quasi-experimental case-control study including 500 patients undertaking prehabilitation, as intervention group, and 250 patients following standard conventional care before surgery. the patients will be included from the following type of surgeries (2:1 intervention to control ratio): major digestive surgery (n, 525), lung volume reduction (n, 30), radical cystectomy (n, 30), major cardiovascular surgery (n, 165). study groups will be made comparable using propensity score matching with the following matching variables: type of surgery, age, sex and adjusted morbidity groups (gma) scoring.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) candidates to colorectal surgery, esophagectomy, gastrectomy, gastric bypass, major liver resection, pancreas resection, lung volume resection, radical cystectomy, cardiac valve surgery or cardiac revascularization. * patients at high-risk for surgical complications defined by age \> 70 years old and/or american society of anesthesiologists 3-4. exclusion criteria: * non-elective surgery * metastatic disease known preoperatively * unstable cardiac or respiratory disease * locomotor limitations precluding exercise performance * cognitive deterioration impeding adherence to the program

Keywords: prehabilitation physical activity integrated care collaborative self-management
evaluation of the covid-19 infection response in patients admitted to the emergency department for dyspnea

Conditions: Emergencies

Summary: this research aims to improve our knowledge of the epidemiology of patients consulting in the covid-19 possible respiratory units (recop unit). indeed, the epidemic linked to covid-19 affects france and impacts its health system. the reception of all intermediate patients will be on the emergency structures (su). indeed, the french healthcare system centralizes unscheduled urgent care on the er. the aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to su or the diagnostic approach to respiratory difficulty may be carried out. a central issue of this diagnostic strategy will be to be rapid, since the diagnosis will have to be made in the context of significant flows, with a need to quickly refer patients to the most suitable downstream service, while limiting the risk contamination of caregivers and vulnerable patients if a covid-19 + patient is admitted to an unsuitable service. however, virological tests do not currently allow rapid results for covid-19. research project of investigatory aims to develop a predictive model of the risk of being covid-19 positive for patients admitted to the emergency room for acute dyspnea.


Eligibility criteria:
inclusion criteria: * all patients over 15 years admitted to the recop unit for dyspnea exclusion criteria: * patient admitted to shock for respiratory distress requiring immediate respiratory support. * patient under justice safeguard

Keywords: covid-19 diagnostic strategy acute dyspnea
the aim of this project is to verify whether a depletion of b cell memory subpopulation ("marginal-zone-like") cd19 + igd + cd27 + and cd19 + igm + cd27 + is a useful indicator of hyposplenism in patients with celiac disease

Conditions: Celiac Disease

Summary: this project is expected to confirm the hypothesis that hyposplenism in patients with celiac disease is not conditioned by a selective memory deficiency of b lymphocytes. other objectives of project are: * determination of gliadin 33-mer in faecal and urine as indicators patient´s adherence to gluten-free diet * determination of citrulline in plasma as an indicator of the overall functional capacity enterocytes

ultrasound examination is focused to spleen size (spleen volumetry). methodology of laboratory examinations is based on venous blood sampling for the determination of memory b-like marginal zone by flow cytometry; gliadin 33-mer (elisa) determination in faecal and urine sample; blood plasma extraction for citrulline (high performance liquid chromatography, hplc).

Eligibility criteria:
inclusion criteria: * diagnosed celiac disease * age over 18 years exclusion criteria: * haematological diseases and cancer * infectious and non-infectious inflammation of the small intestine * congenital or acquired immunodeficiency * autoimmune disease * immunosuppressant treatment * diabetes mellitus * pregnancy and lactation

Keywords: celiac sprue, celiac, hyposplenism, igm memory, b lymphocytes